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Accenture
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Boehringer Ingelheim
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020232

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NDA 020232 describes FIORICET W/ CODEINE, which is a drug marketed by Actavis Labs Ut Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the FIORICET W/ CODEINE profile page.

The generic ingredient in FIORICET W/ CODEINE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Summary for 020232
Tradename:FIORICET W/ CODEINE
Applicant:Actavis Labs Ut Inc
Ingredient:acetaminophen; butalbital; caffeine; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020232
Suppliers and Packaging for NDA: 020232
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIORICET W/ CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 020232 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3220 N 0591-3220-01
FIORICET W/ CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 020232 ANDA Physicians Total Care, Inc. 54868-5162 E 54868-5162-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Jul 30, 1992TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Dow
Fish and Richardson
Colorcon
AstraZeneca
Baxter
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Julphar
Chubb

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